iBio, Inc. (IBIO) Announces Production of Biosimilar Palivizumab with its iBioLaunch(TM) Technology

4/10/2012 9:27:58 AM

NEWARK, Del., April 10, 2012 /PRNewswire/ -- iBio, Inc. (NYSE AMEX: IBIO) announced that its proprietary iBioLaunch technology for the production of biotherapeutic proteins and vaccine antigens in whole green plants has been used to produce a functional monoclonal antibody copy of palivizumab, a humanized monoclonal antibody that binds to respiratory syncytial virus (RSV) glycoprotein fusion protein (F), and inhibits viral entry into cells. Palivizumab is used to reduce RSV associated hospitalizations, but its high cost limits treatment to high-risk infants who receive monthly intramuscular injections throughout the RSV season. Worldwide annual sales of palivizumab exceed $900 million.

Scientists at iBio's research and development partner, Fraunhofer USA Center for Molecular Biotechnology, have expressed the antibody heavy and light chains in green tissues of plants using an iBioLaunch vector system developed for multi-chain proteins such as antibodies. The expression of palivizumab in plants resulted in self-assembly of the appropriate antibody quaternary structure, which was then recovered from the plant tissue.

iBioLaunch-produced palivizumab was shown to bind inactivated RSV, indicating that it recognizes F antigen presented on the virus' surface. Furthermore, plant-produced palivizumab was demonstrated to have a dose-dependent RSV neutralizing activity in a plaque reduction neutralization test. The effective concentration to observe 50% plaque reduction is comparable for plant-produced palivizumab to that reported for palivizumab manufactured in recombinant mammalian cells. The virus neutralizing activity observed is specific to palivizumab, as demonstrated with the use of an unrelated, plant-produced monoclonal antibody as a negative control for any plant-specific activity.

The production of functional palivizumab in plants extends the number of monoclonal antibodies that have been produced using the iBioLaunch system. All the monoclonal antibodies manufactured using iBioLaunch technology have been shown to be correctly assembled and fully active in appropriate bioassays.

About iBio, Inc.

iBio develops and offers product applications of its iBioLaunch platform, providing collaborators full support for turn-key implementation of its technology for both proprietary and biosimilar products. The iBioLaunch platform is a proprietary, transformative technology for development and production of biologics using transient gene expression in unmodified green plants. Advantages over other systems include: success with proteins difficult or impossible to produce with other methods; broadly applicable to biologics, including monoclonal antibodies, other therapeutic proteins and vaccines; enables rapid development and validation of modular, scalable, and optionally robotic, multi-product manufacturing facilities; production time measured in weeks instead of months or more. Additional benefits include a practically unlimited surge capacity for remedial action against bioterrorism and pandemic disease; product entry that is unconstrained by traditional process patents, and significantly lower capital and operating costs for comparable production. Further information is available at: www.ibioinc.com.

Forward-Looking Statements

Statements included in this news release related to iBio, Inc. may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as competitive factors, technological development, market demand, and the Company's ability to obtain new contracts and accurately estimate net revenues due to variability in size, scope and duration of projects. Further information on potential risk factors that could affect the Company's financial results can be found in the company's Reports filed with the Securities and Exchange Commission.